Cleared Traditional

Stryker Orthopaedics Hip Systems Labeling Update

K233498 · Howmedica Osteonics Corp., Dba Stryker Orthopaedics · Orthopedic

Dec 2023

Decision

51d

Days

Class 2

Risk

About This 510(k) Submission

K233498 is an FDA 510(k) clearance for the Stryker Orthopaedics Hip Systems Labeling Update, a Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (Class II — Special Controls, product code LPH), submitted by Howmedica Osteonics Corp., Dba Stryker Orthopaedics (Malwah, US). The FDA issued a Cleared decision on December 21, 2023, 51 days after receiving the submission on October 31, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3358.

Submission Details

510(k) Number	K233498 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 31, 2023
Decision Date	December 21, 2023
Days to Decision	51 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	LPH — Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3358